TherapeuticsMD Announces Second Quarter 2014 Financial Results

Company Significantly Strengthens Cash Balance with Recent Equity Offering

Combination and VVA Hormone Therapy Programs Advancing on Schedule

Management to Host Conference Call Today at 4:30 p.m. EDT

BOCA RATON, Fla.--()--TherapeuticsMD Inc. (NYSE MKT:TXMD), a women’s healthcare company, today announced its financial results for the quarter ended June 30, 2014.

Second Quarter 2014 and Recent Developments

  • Net revenue increased to $3.8 million from $2.1 million for the prior year’s quarter
  • Net loss was $10.9 million compared with $6.0 million for the prior year’s quarter
  • Received notification of issuance for two additional patents regarding combination hormone therapies generated by the company’s SYMBODA technology
  • Received positive input from FDA regarding advancement of the phase 3 study for TX-004HR (VagiCap), the first softgel vaginal suppository for treatment of vulvar vaginal atrophy ("VVA")
  • Ended the quarter with $35.6 million in cash and recently completed $46 million equity offering

"During the second quarter, we continued recruitment in the ongoing REPLENISH phase 3 study for our combination hormone therapy pill, engaged a contract research organization to start up our phase 3 study of VagiCap in the VVA indication, and strengthened our intellectual property position with notification of two new patent allowances," said TherapeuticsMD CEO Robert G. Finizio. "More recently, we’ve solidified our cash position through a recent equity offering, providing us with additional resources to advance our ongoing programs and support our earlier stage pipeline, including novel transdermal product opportunities that leverage our proprietary SYMBODA technology."

Summary of Financial Results

For the second quarter of 2014, net revenue was $3.8 million compared with $2.1 million during the prior year period. This increase was largely driven by continued growth of the company’s current women’s health products, including the launch of additional prenatal vitamin products.

Cost of goods sold increased to $0.9 million for the second quarter of 2014 compared with $0.5 million for the prior year quarter.

Total operating expenses for the second quarter of 2014 were $13.8 million, compared with $7.2 million for the prior year quarter. The increase was primarily due to higher research and development (R&D) expenses related to late-stage clinical trials for hormone therapy product candidates. R&D expenses for the second quarter of 2014 were $8.2 million, including clinical costs associated with multiple phase 3 clinical development programs, compared to $1.7 million for the prior year quarter. Sales, general and administration expenses for the quarter were $5.5 million, relatively flat compared with the prior year quarter.

Net loss was $10.9 million for the second quarter of 2014, or $0.07 per basic and diluted share, compared with $6.0 million, or $0.05 per basic and diluted share, in the prior year quarter.

At June 30, 2014, TherapeuticsMD had cash of approximately $35.6 million, compared to approximately $54.2 million at December 31, 2013. The company recently completed a public offering of shares of its common stock for gross proceeds of approximately $46 million. The proceeds will be used toward development of the company’s late-stage pipeline of novel hormone therapies and to support advancement of its earlier stage and preclinical programs.

As of August 4, 2014, there were 155,807,765 shares of the company's common stock outstanding.

Conference Call Today

As previously announced, TherapeuticsMD will host a conference today to discuss these financial results and provide a business update which may include forward-looking statements. Details for the conference call include:

Date   August 6, 2014
Time   4:30pm EDT
Telephone access: U.S. and Canada   866-665-9531
Telephone access: International   724-987-6977
Access code for all callers   81301505
Live audio webcast  

www.therapeuticsmd.com

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About TherapeuticsMD

TherapeuticsMD Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. TherapeuticsMD is developing advanced hormone therapy pharmaceutical products based on novel technologies that enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company also manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under the vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com, and www.bocagreenmd.com.

Except for the historical information contained herein, the matters set forth in this press release, including statements relating to future events or performance, including statements regarding the company’s performance; the significantly strengthened cash balance; the combination and VVA therapy programs advancing on schedule; the receipt of additional patents generated by the company’s SYMBODA technology; positive input from FDA regarding advancement of phase 3 study for VagiCap; the continued recruitment in the ongoing REPLENISH phase 3 study; the engagement of a contract research organization for phase 3 study of VagiCap; the strengthening of the company’s intellectual property position; the solidification of the company’s cash position; the advancement of the company’s ongoing programs or support the company’s early stage pipeline, including novel transdermal product opportunities that leverage SYMBODA technology; the increase in sales driven by continued growth of the company’s current women’s health products; the launch of additional prenatal vitamins; the impact of development of the company’s late-stage pipeline of novel hormone therapies or advancement of the company’s early stage and preclinical programs are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with the company’s business and finances in general; and other risks detailed in the company’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K filed on March 5, 2014, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
 
    June 30, 2014   December 31, 2013
(Unaudited)
ASSETS
Current Assets:
Cash $ 35,553,836 $ 54,191,260
Accounts receivable, net of allowance for doubtful accounts
of $27,948 and $26,555 respectively 2,164,738 1,690,753
Inventory 1,452,994 1,043,618
Other current assets   2,678,200     2,477,715  
Total current assets   41,849,768     59,403,346  
 
Fixed assets, net   76,689     61,318  
 
Other Assets:
Prepaid expense 1,511,549 1,750,455
Intangible assets 867,107 665,588
Security deposit   125,000     135,686  
Total other assets   2,503,656     2,551,729  
 
Total assets $ 44,430,113   $ 62,016,393  
 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $ 2,330,257 $ 2,114,217
Deferred revenue 1,287,796 1,602,580
Other current liabilities   3,329,418     3,601,189  
Total current liabilities   6,947,471     7,317,986  
 
Commitments and Contingencies
 
Stockholders' Equity:
Preferred stock - par value $0.001; 10,000,000 shares authorized;
no shares issued and outstanding - -
Common stock - par value $0.001; 250,000,000 shares authorized;
145,926,973 and 144,976,757 issued and outstanding, respectively 145,927 144,977
Additional paid-in capital 137,951,719 135,086,056
Accumulated deficit   (100,615,004 )   (80,532,626 )
Total stockholder' equity   37,482,642     54,698,407  
 
Total liabilities and stockholders' equity $ 44,430,113   $ 62,016,393  
 
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 
    Three Months Ended   Six Months Ended
June 30, June 30,
  2014       2013     2014       2013  
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
 
Revenues, net $ 3,751,778 $ 2,080,885 $ 6,582,311 $ 3,618,080
 
Cost of goods sold   892,956     463,606     1,723,663     843,952  
 
Gross profit   2,858,822     1,617,279     4,858,648     2,774,128  
 
Operating expenses:
Sales, general, and administration 5,537,164 5,476,553 10,566,661 10,003,135
Research and development 8,234,641 1,747,084 14,142,719 3,312,285
Depreciation and amortization   14,094     10,636     27,162     18,593  
Total operating expense   13,785,899     7,234,273     24,736,542     13,334,013  
 
Operating loss   (10,927,077 )   (5,616,994 )   (19,877,894 )   (10,559,885 )
 
Other income (expense):
Miscellaneous income 18,579 3,479 37,151 3,479
Interest income 9,238 - 18,392 -
Interest expense - (150 ) - (1,165,981 )
Financing costs - (395,981 ) (260,027 ) (659,968 )
Loan guaranty costs   -     -     -     (2,944 )
Total other income (expense)   27,817     (392,652 )   (204,484 )   (1,825,414 )
 
Loss before taxes (10,899,260 ) (6,009,646 ) (20,082,378 ) (12,385,299 )
 
Provision for income taxes   -     -     -     -  
 
Net loss $ (10,899,260 ) $ (6,009,646 ) $ (20,082,378 ) $ (12,385,299 )
 
Loss per share, basic and diluted:
 
Net loss per share, basic and diluted $ (0.07 ) $ (0.05 ) $ (0.14 ) $ (0.11 )
 
Weighted average number of common
shares outstanding   145,485,505     130,851,978     145,253,818     116,866,764  
 
THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 
    Six Months Ended
June 30,
  2014       2013  
(Unaudited) (Unaudited)
 
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (20,082,378 ) $ (12,385,299 )
Adjustments to reconcile net loss to net cash flows used in
operating activities:
Depreciation 15,591 12,084
Amortization of intangible assets 11,570 6,509
Provision for doubtful accounts 1,393 58,337
Stock based compensation 2,268,599 1,179,912
Stock based expense for services 481,024 637,155
Amortization of deferred financing costs 260,027 659,938
Amortization of debt discount - 1,102,680
Loan guaranty costs - 2,944
Changes in operating assets and liabilities:
Accounts receivable (475,378 ) (409,475 )
Inventory (409,376 ) 109,151
Other current assets (460,512 ) (1,696,551 )
Other assets (18,392 ) (899,000 )
Accounts payable 216,040 403,750
Deferred revenue (314,784 ) 74,320
Accrued expenses and other current liabilities   (271,771 )   458,792  
 
Net cash flows used in operating activities   (18,778,347 )   (10,684,753 )
 
CASH FLOWS FROM INVESTING ACTIVITIES
Patent and trademark costs, net of abandoned costs (213,089 ) (112,192 )
Purchase of property and equipment (30,962 ) (22,905 )
Refund (payment) of security deposit   10,686     (125,000 )
 
Net cash flows used in investing activities   (233,365 )   (260,097 )
 
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from exercise of options 287,288 6,231
Proceeds from exercise of warrants 87,000 -
Proceeds from sale of common stock, net - 48,512,460
Proceeds from line of credit - 500,000
Repayment of line of credit - (500,000 )
Repayment of notes payable   -     (4,691,847 )
 
Net cash flows provided by financing activities   374,288     43,826,844  
 
(Decrease) increase in cash (18,637,424 ) 32,881,994
Cash, beginning of period   54,191,260     1,553,474  
Cash, end of period   35,553,836     34,435,468  
 
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
 
Cash paid for interest $ -   $ 212,853  
 
Cash paid for income taxes $ -   $ -  
 
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:
 
Warrants issued for financing $ -   $ 1,711,956  
Warrants issued for services $ -   $ 462,196  

Contacts

TherapeuticsMD Inc.
For Investors:
Dan Cartwright, 561-961-1900
Chief Financial Officer
Dan.Cartwright@TherapeuticsMD.com
or
For Media:
Julia Amadio, 561-961-1900
Chief Product Officer
Julia.Amadio@TherapeuticsMD.com

Release Summary

TherapeuticsMD, Inc. announces results of second quarter ended June 30, 2014

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Contacts

TherapeuticsMD Inc.
For Investors:
Dan Cartwright, 561-961-1900
Chief Financial Officer
Dan.Cartwright@TherapeuticsMD.com
or
For Media:
Julia Amadio, 561-961-1900
Chief Product Officer
Julia.Amadio@TherapeuticsMD.com